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Vibration Response Imaging (VRI) in Lung Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00744822
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : September 1, 2008
Sponsor:
Collaborator:
Deep Breeze
Information provided by:
Hannover Medical School

Brief Summary:
This study is a prospective, multi-center study. 50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months These patients will undergo a baseline VRI recording prior to the interventional procedure and a follow-up VRI at 1 hour after the interventional procedure. Furthermore, the patients will be recorded at the designated follow-up periods of 1, 3 and 6-month (+ 7 days) post-baseline visit, as well as before and 1 hour after any recurrent interventional procedure

Condition or disease
Lung Transplantation

Detailed Description:
  • Study participants will be patients who have undergone lung transplantation during the last 6 months and are in a stable clinical position at the time of enrollment.
  • Patients who meet the study inclusion and exclusion criteria will be enrolled in the study.
  • The enrolled patients will be recorded with the VRI at each occurrence in which the standard procedures are performed:

    • Baseline after study enrollment (VRI Recording 1 + standard evaluations).
    • At each follow-up visit [1, 3, 6 months after baseline visit] during the 6 month follow-up period of the study (VRI Recordings + standard evaluations (if possible)).
    • In the event of bronchoscopic intervention, then before the interventional procedure (VRI Recording 1 + standard evaluations) and before any recurrent interventional procedures (VRI Recordings + standard evaluations) during the course of the study (6-month follow-up period).
    • 1 hour after all bronchoscopic interventional procedures.
    • In the event of an unanticipated visit, then a VRI recording will be performed (VRI Recordings + standard evaluations).
  • All subjects will be recorded according to a standard procedure; moreover, it is essential that for each subject repeatable recordings will be performed in the same manner (i.e. breathing manner and matrix placement). Each VRI recording session will take ~15 minutes [the actual recording is ~2 minutes for placement and breathing/recording].
  • Standard evaluation procedures may include any of the following:

    • Lung function tests (this test is required at all visits)
    • Physical examination
    • Bronchoscopy (e.g. transbronchial biopsy)
    • CT-imaging
    • Chest x-ray
    • V/Q Scan (Baseline visit for single lung transplantation)
    • Blood gases (this test is required at all visits)
    • Blood tests

Study Type : Observational
Actual Enrollment : 55 participants
Time Perspective: Prospective
Official Title: Vibration Response Imaging (VRI) in Lung Transplant Recipients
Study Start Date : March 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The primary study objective is to evaluate the ability of VRI lung images in single lung or double lung transplant recipients to assist the physician in detecting risk factors associated with lung transplantation during the six-month follow-up period [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The secondary objective is to compare evaluations of the lung VRI images with the results of other evaluation techniques [i.e. PFT, chest X-ray]. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months
Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be entered into the study:

  1. Able and willing to read, understand, and provide written Informed Consent
  2. Male or Female in the age range of 18-65 years
  3. Subject is a lung transplant recipient who underwent single or double lung transplantation within the last 6 months
  4. BMI > 19
  5. Height of >1.55 meters
  6. Stable clinical condition at study baseline evaluation

Exclusion Criteria:

Any of the following will exclude the subject from study:

  1. Intubated patients
  2. Chest wall deformation
  3. Spine deformation (including severe scoliosis)
  4. Hirsutism
  5. Potentially contagious skin lesion on the back
  6. Skin lesion that would interfere with sensor placement
  7. Cardiac pacemaker or implantable defibrillator
  8. Patient is pregnant as confirmed with urine pregnancy test
  9. Colonization of multi-resistant bacteria (MRSA) If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744822


Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Deep Breeze
Investigators
Principal Investigator: Tobias Welte, MD Hannover Medical School

Responsible Party: Merav Gat, Director of Clinical Affairs, Deep Breeze Ltd.
ClinicalTrials.gov Identifier: NCT00744822     History of Changes
Other Study ID Numbers: 4066
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: September 1, 2008
Last Verified: December 2005

Keywords provided by Hannover Medical School:
Lung Transplantation
Infections
Graft Rejection